Objectives: To assess the effect of Thymus vulgari concentration on the duration of diarrhea in children with acute watery diarrhea. Design: A double-blind randomized clinical trial. Setting and conduct: The eligible patients with complaints of diarrhea referred to Shahid Beheshti Hospital will be enrolled into the trial. Inclusion criteria: Age 1-5 years, Acute watery diarrhea. Exclusion criteria: High fever (T>38.5°C), Severe dehydration, Bloody diarrhea, Severe malnutrition, Using of antibiotics or anti-diarrheall drugs, Patients with more than one complain, Immune deficiency. Intervention group: Oral administration of Thymus vulgari concentration 2.5 milliliters every 8 hours for 5 days plus ORS. Control group: Oral administration of placebo 2.5 milliliters every 8 hours for 5 days plus ORS. Primary outcome: Duration of diarrhea by asking from patient or mother, frequency of diarrhea by asking from patient or mother.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016123011145N19
Registration date:2017-02-27, 1395/12/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-27, 1395/12/09
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research and Technology, Kashan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Thymus vulgari concentration on duration of acute diarrhea in children
Public title
The therapeutic effect of Thymus vulgari concentration on acute diarrhea in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 1-5 years; Acute watery diarrhea Exclusion criteria: High fever (T>38.5°C); Severe dehydration; Bloody diarrhea; Severe malnutrition; Using of antibiotics or anti-diarrheall drugs; Patients with more than one complain; Immune deficiency
Age
From 1 year old to 5 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.KAUMS.REC.1395.136
Health conditions studied
1
Description of health condition studied
Acute watery diarrhea
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Duration of diarrhea
Timepoint
Daily
Method of measurement
Asking from patient or mother
2
Description
Frequency of diarrhea
Timepoint
Daily
Method of measurement
Asking from patient or mother
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral administration of Thymus vulgari concentration 2.5 milliliters every 8 hours for 5 days plus ORS.
Category
Treatment - Drugs
2
Description
Control group: Oral administration of placebo 2.5 milliliters every 8 hours for 5 days plus ORS.